PMID- 25155146
OWN - NLM
STAT- MEDLINE
DCOM- 20150825
LR  - 20220409
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 16
IP  - 12
DP  - 2014 Dec
TI  - Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist 
      albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a 
      randomized, double-blind, placebo-controlled trial in patients with type 2 
      diabetes mellitus not controlled on pioglitazone, with or without metformin.
PG  - 1257-64
LID - 10.1111/dom.12382 [doi]
AB  - AIMS: To show that albiglutide, a glucagon-like peptide-1 receptor agonist, is an 
      effective and generally safe treatment to improve glycaemic control in patients 
      with type 2 diabetes mellitus whose hyperglycaemia is inadequately controlled 
      with pioglitazone (with or without metformin). METHODS: In this 3-year, 
      randomized, double-blind, placebo-controlled study, 310 adult patients on a 
      regimen of pioglitazone (with or without metformin) were randomly assigned to 
      receive additional treatment with albiglutide [30 mg subcutaneous (s.c.) once 
      weekly, n = 155] or matching placebo (n = 155). The primary efficacy endpoint was 
      change from baseline to week 52 (intention-to-treat) in glycated haemoglobin 
      (HbA1c). RESULTS: The model-adjusted change from baseline in HbA1c at week 52 was 
      significantly better with albiglutide than with placebo (-0.8%, 95% confidence 
      interval -1.0, -0.6; p < 0.0001). Change from baseline fasting plasma glucose was 
      -1.3 mmol/l in the albiglutide group and +0.4 mmol/l in the placebo group (p < 
      0.0001); a significantly higher percentage of patients reached the HbA1c goals 
      with albiglutide (p < 0.0001), and the rate of hyperglycaemia rescue up to week 
      52 for albiglutide was 24.4 versus 47.7% for placebo (p < 0.0001). Albiglutide 
      plus pioglitazone had no impact on weight, and severe hypoglycaemia was observed 
      rarely (n = 2). With few exceptions, the results of safety assessments were 
      similar between the groups, and most adverse events (AEs) were mild or moderate. 
      The 52-week incidence rates for gastrointestinal AEs for albiglutide and placebo 
      were: 31.3 and 29.8%, respectively (diarrhoea: 11.3 and 8.6%; nausea: 10.7 and 
      11.3%; vomiting: 4.0 and 4.0%). CONCLUSIONS: Albiglutide 30 mg administered once 
      weekly as an add-on to pioglitazone (with or without metformin) provided 
      effective and durable glucose lowering and was generally well tolerated.
CI  - (c) 2014 John Wiley & Sons Ltd.
FAU - Reusch, J
AU  - Reusch J
AD  - Department of Endocrinology, Denver Veterans Administration Medical Center, 
      Denver, CO, USA.
FAU - Stewart, M W
AU  - Stewart MW
FAU - Perkins, C M
AU  - Perkins CM
FAU - Cirkel, D T
AU  - Cirkel DT
FAU - Ye, J
AU  - Ye J
FAU - Perry, C R
AU  - Perry CR
FAU - Reinhardt, R R
AU  - Reinhardt RR
FAU - Bode, B W
AU  - Bode BW
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141006
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Incretins)
RN  - 0 (Thiazolidinediones)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
RN  - 9100L32L2N (Metformin)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Blood Glucose/*drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucagon-Like Peptide 1/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Humans
MH  - Hypoglycemia/chemically induced/*prevention & control
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Incretins
MH  - Male
MH  - Metformin/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Pioglitazone
MH  - Thiazolidinediones/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - albiglutide
OT  - glucagon-like peptide-1 agonist
OT  - incretins
OT  - type 2 diabetes
EDAT- 2014/08/27 06:00
MHDA- 2015/08/26 06:00
CRDT- 2014/08/27 06:00
PHST- 2014/05/12 00:00 [received]
PHST- 2014/08/09 00:00 [revised]
PHST- 2014/08/18 00:00 [accepted]
PHST- 2014/08/27 06:00 [entrez]
PHST- 2014/08/27 06:00 [pubmed]
PHST- 2015/08/26 06:00 [medline]
AID - 10.1111/dom.12382 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2014 Dec;16(12):1257-64. doi: 10.1111/dom.12382. Epub 2014 
      Oct 6.